This page provides an independent statistical analysis and educational interpretation of publicly reported results. ClinicalTrials.gov provides the official trial registry record. Numerical trial results on this page are restricted to the results posted in the ClinicalTrials.gov record; calculations added by Clinical Biostats are labelled as such.
1. Trial at a Glance
This page covers the registry results for Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach (NCT01161329), a randomized phase 1 study. The primary outcome is The Berg Balance Scale (BBS).
| Feature | Registry value |
|---|---|
| ClinicalTrials.gov identifier | NCT01161329 |
| Phase | Phase 1 |
| Condition | Stroke |
| Allocation | Randomized |
| Design model | Parallel |
| Masking | Single |
| Enrollment | 67 |
| Arms in the primary outcome | n/a |
| Lead sponsor | Uppsala University |
| Results posted | Yes |
2. Clinical Question
The trial asked whether a group program combining high-intensity functional exercise with motivational discussions could influence functioning and other health measures in people who had experienced a stroke. The registry describes the intended comparison as a randomized controlled study, with the intervention group undertaking exercise and discussions and the control group instructed to continue ordinary life.
Population
People who had experienced a stroke one year earlier are the population described in the study summary. The registry lists Stroke as the condition and reports enrollment of 67. Further eligibility criteria and the characteristics of participants at baseline are not reported in the registry record.
Intervention
The intervention is the High-Intensity Functional Exercise Program, described as exercise two times/week in groups of 5-7 patients, combined with motivational discussions. The registry characterizes the approach as both physical and behavioural.
Comparator
Participants in the control group were instructed to live their ordinary life. The registry does not describe additional control-group activities, restrictions, or the extent to which usual care was specified.
Primary question
The named primary endpoint is the Berg Balance Scale (BBS), measured at baseline, after 3, 6 months and after 1 year. The scale records balance, with higher scores indicating better balance. The registry does not report the group scores, the between-group comparison, or uncertainty around any comparison.
The study summary also describes intended assessment of physical activity, motor function, depression, health-related quality of life, anthropometric and biochemical factors, falls, and fall-related beliefs. Those aims provide context for the broad physical and psychosocial focus, but the registry record does not give numerical results for those measures. The primary question can therefore be described from the stated endpoint and design, but the magnitude and precision of any result cannot be judged from the record.
3. Trial Design
The registry describes a randomized, single-masked, parallel-group study, classified as Phase 1. It lists Uppsala University as sponsor and reports enrollment of 67. The study status is completed; the recorded start is 2009-09 and primary completion is 2012-07. The registry does not report who was masked, how randomization was generated or concealed, or whether masking was maintained.
The intervention was the High-Intensity Functional Exercise Program (HIFE). The intervention-group description specifies exercise two times/week in groups of 5-7 patients together with motivational discussions. The control-group description says participants were instructed to live their ordinary life. These descriptions identify the planned contrast, but they do not establish how consistently participants attended, whether the intervention was delivered as intended, or what care participants received outside the described activities. Those details are not reported in the registry record.
The primary outcome is the Berg Balance Scale, assessed at baseline and at follow-up after 3, 6 months and after 1 year. The outcome is recorded as a mean with standard deviation. Although the study summary refers to disability as the primary outcome focus, the named endpoint measures balance. Balance is relevant to function, but the registry does not define the BBS as a comprehensive measure of disability.
The record counts 2 outcome measures and 2 analyses, but details of those analyses are not reported in the registry record. The full eligibility criteria, participant flow, actual allocation by group, adherence, withdrawals, and analysis populations are also not reported. The equal-allocation statement belongs to the sample-size planning assumptions and should not be read as evidence of the actual allocation achieved.
4. Participant Flow and Accounting
The registry reports how participants moved through each stage of the study. All counts below are exactly as posted; missing counts are not inferred from other stages.
Before assignment: Of the 195 eligible participants 124 were ineligible and 4 declined participation..
Overall Study
| Stage | Controlgroup | Intervention Group |
|---|---|---|
| STARTED | 33 | 34 |
| COMPLETED | 29 | 24 |
| NOT COMPLETED | 4 | 10 |
5. Baseline Characteristics
The table reproduces the baseline characteristics posted in the registry, which describe the participants analysed at baseline and help show whether the randomized groups were comparable.
| Characteristic | Unit | Controlgroup | Intervention Group | Total |
|---|---|---|---|---|
| Participants analysed | 33 | 34 | 67 | |
| Age, Continuous | years | 73.7 (SD 5.3) | 72.6 (SD 5.5) | 73.1 (SD 5.4) |
| Sex: Female, Male: Female | Participants | 9 | 7 | 16 |
| Sex: Female, Male: Male | Participants | 24 | 27 | 51 |
| Region of Enrollment: Sweden | participants | 33 | 34 | 67 |
| Months since stroke | months | 13 (12 to 14) | 13 (12 to 16) | 13 (12 to 16) |
6. Primary Endpoint
The registry lists the primary outcome as The Berg Balance Scale (BBS), measured over baseline, after 3, 6 months and after 1 year.
| Element | Registry entry |
|---|---|
| Result type | Mean |
| Measure of spread | Standard Deviation |
| Unit | units on a scale |
| Endpoint classification | Continuous Endpoint |
The primary endpoint is the Berg Balance Scale (BBS), reported in units on a scale. The registry describes a total score range of 0-56 Points and states that higher scores indicate better balance. It lists measurements at baseline, after 3, 6 months and after 1 year, with the outcome expressed as a mean and standard deviation.
Balance is a functional domain that can be relevant when studying people after stroke. A standardized scale gives a structured way to describe balance at the stated assessment times. In general, a mean describes the group’s central score, while a standard deviation describes the spread of scores around that mean. Neither statistic alone establishes whether groups differ, or how precisely a difference is estimated.
The study summary frames disability as the primary outcome focus, while the registry names balance as the primary endpoint. These concepts are related but not identical: the named scale records balance rather than every aspect of disability or participation. The registry does not report the group means, standard deviations, change scores, or a between-group estimate for the BBS. It is therefore not possible to assess the observed balance results or their precision from the registry record.
7. Why No Re-analysis Is Shown
8. Statistical Interpretation
The registry describes a randomized comparison and identifies the BBS as the primary endpoint, but it does not report numerical BBS results. No group means, standard deviations, treatment contrast, confidence interval, or p-value are reported in the registry record. As a result, the magnitude, direction, and precision of the primary-outcome comparison cannot be evaluated from the recorded information. The fact that the study is marked completed does not supply those missing results.
The stated scale range is 0-56 Points, and higher scores indicate better balance. This gives the endpoint a clear direction of interpretation: a higher score represents better balance on the scale. But without the actual group scores or a contrast between groups, that direction cannot be used to describe what happened in the trial. No claim about improvement, lack of improvement, or a difference between groups is warranted from the information recorded.
The registry’s enrollment figure is 67. Enrollment does not establish how many participants contributed to each assessment or analysis. The actual group sizes, losses to follow-up, missing outcome values, and analysis population are not reported in the registry record. A reader should not infer that every enrolled participant completed every follow-up assessment.
The listed follow-up schedule includes baseline, after 3, 6 months and after 1 year. Repeated measurements can describe how scores change over time, but a time pattern within one group is not by itself a randomized comparison. The relevant contrast would depend on the statistical analysis and the data available at each assessment. The registry does not describe the model or contrast used to analyze the repeated BBS measurements.
The study summary also lists intended outcomes across physical activity, motor function and balance, psychosocial measures, body composition and biochemical factors, and falls-related measures. The registry counts 2 outcome measures and 2 analyses, but does not identify the full analysis details or report numerical findings for these domains. Thus the broad range of stated aims should not be mistaken for evidence that results are available for each outcome.
The safety record lists zero serious adverse events and zero other adverse events for the reported at-risk group counts, while deaths are not reported. These recorded counts describe the entries in the registry; they do not fill the gap in primary-outcome results. They also do not establish that every possible harm was systematically captured or reported.
Overall, the registry supports a description of the intended randomized design, intervention, comparator, and primary measure. It does not support a quantitative conclusion about the balance outcome. Any interpretation of the trial’s efficacy or precision would require outcome results and analysis details that are not reported in the registry record.
9. Statistical Methods Explained
The registry identifies a randomized, parallel-group study and describes the BBS as a continuous outcome summarized by a mean and standard deviation. It does not report the statistical analysis plan, the method used to compare groups, the handling of repeated measurements, or the method for missing data. The concepts below are general explanations of how such analyses may be understood; they are not claims about methods used in this trial.
What does a mean and standard deviation describe?
In general, a mean gives a compact description of the center of a set of scores. A standard deviation describes how dispersed individual scores are around that mean. For a continuous scale, these summaries can help characterize each group at an assessment time. They do not, by themselves, give the randomized treatment contrast, and they do not describe how uncertain that contrast is. The registry reports that the BBS was summarized using a mean and standard deviation, but the numerical summaries are not reported in the registry record.
What would a between-group comparison answer?
In general, a randomized trial comparison asks how the outcome differs between the assigned groups. A comparison can be expressed as a difference in mean scores, a difference in change from baseline, or a model-based contrast. These approaches answer related but not necessarily identical questions. A baseline-adjusted analysis, for example, would estimate a follow-up contrast while accounting for baseline score; a change-score analysis would compare changes. The registry does not report which contrast or model was used, so neither should be attributed to this trial.
A confidence interval is a way to communicate the precision of an estimated contrast. It gives a range of values compatible with the data and the analysis assumptions at a chosen confidence level. A narrower interval generally indicates greater precision than a wider one. The interval does not eliminate uncertainty, and it cannot be interpreted without knowing the estimate, method, and confidence level. No confidence interval or confidence level for the BBS comparison is reported in the registry record.
A p-value, when used, describes how compatible the observed data are with a specified null model under the analysis assumptions. It does not measure the size or importance of an effect, and it is not the probability that a treatment works. The registry record does not report a p-value for the primary endpoint, nor does it describe a significance-testing procedure. No statistical-significance conclusion can be drawn from the recorded endpoint description alone.
Why do repeated assessments matter?
General statistical principle: measurements from the same participant over time are usually related, rather than independent observations. An analysis of repeated assessments should account for that dependence if it uses measurements across multiple times. The BBS schedule includes baseline, after 3, 6 months and after 1 year, so a longitudinal analysis might address both group differences and changes over time. However, the registry does not state whether the investigators used a repeated-measures model, analyzed each follow-up separately, selected a particular time point, or used another approach.
Different analysis choices can lead to different estimands. A comparison at a single follow-up addresses the groups’ scores at that time. A comparison of change addresses differences in movement from baseline. A model using all assessments can estimate a pattern across time, subject to its assumptions. These are general distinctions, not descriptions of the analysis in this trial. The registry does not identify a primary contrast beyond naming the BBS and its assessment schedule.
What does over-dispersion mean in general?
General statistical principle: over-dispersion arises when observed variability is greater than a statistical model expects. It is particularly relevant to count outcomes when a model assumes a particular relationship between the mean and variance. If variability is underestimated, standard errors can be too small and confidence intervals too narrow. The named primary endpoint is a scale score summarized by a mean and standard deviation, not a count outcome. The registry does not report an over-dispersion assessment or a model for count outcomes among the broader outcomes mentioned in the study summary.
How should the planning assumptions be read?
The record describes a planning illustration based on the observed effect, using a two-sided significance level of 0.05, equal allocation between the two arms, and a normal approximation. It states that the effect to detect is a stated fraction of the observed effect. The record does not give numerical planning results in the information available for this analysis. Such planning calculations are hypothetical illustrations of sample size under assumptions; they are not observed power and do not establish the achieved precision of this completed study. The actual allocation is not established by the equal-allocation planning assumption.
The planning description also says that non-time-to-event illustrations use participants per arm, whereas time-to-event calculations use total events. The primary endpoint is a continuous BBS measure, and no time-to-event endpoint is identified as primary. The planning assumptions do not substitute for a trial-specific statistical plan, which is not reported in the registry record.
What analysis details remain unknown?
The registry does not report how randomization was implemented, the primary analysis population, adjustment covariates, treatment of participants with missing scores, or sensitivity analyses. It also does not specify whether results were adjusted for baseline, whether the analysis followed randomized assignment, or how any protocol deviations were handled. Those omissions matter because analysis choices define the comparison and can affect both estimates and their uncertainty. No particular method can be inferred from the design label or outcome summary alone.
10. Multiplicity, Missing Data and Analysis Populations
The study summary describes several outcome domains: physical activity, motor function and balance; depression and health-related quality of life; body mass index, metabolic risk profile and inflammation status; and falls, fall-related self-efficacy and outcome expectations. The registry names the BBS as the primary endpoint and counts 2 outcome measures and 2 analyses. It does not report a complete hierarchy of outcomes, analysis details for each measure, or a multiplicity strategy.
In general, testing or estimating many outcomes can create a multiplicity issue. If many hypotheses are tested, the chance of at least one apparently unusual result can increase unless the analysis plan accounts for the number and structure of comparisons. A prespecified primary outcome can help distinguish the main question from secondary analyses, but it does not by itself disclose how the investigators handled multiple outcomes or assessment times. The registry record does not report whether any adjustment or prioritization procedure was used.
Missing-data methods are also not reported in the registry record. The record does not give participant flow by group, the number with BBS measurements at each time, reasons for missing assessments, or assumptions used in any analysis of incomplete data. General statistical principle: results can be sensitive to why measurements are missing and how the analysis handles them. Without those details, the impact of missing data cannot be assessed.
The analysis populations are not reported in the registry record. It is therefore not possible to determine whether analyses used all randomized participants, participants with available outcomes, or another defined population. The registry’s enrollment figure alone does not establish who contributed data to a particular analysis.
11. Safety Results
The registry reports serious adverse events as affected participants divided by participants at risk.
| Arm | Participants with serious adverse events | Participants at risk | Percentage |
|---|---|---|---|
| Controlgroup | 0 | 33 | 0.0% |
| Intervention Group | 0 | 34 | 0.0% |
Other (non-serious) adverse events
Participants with at least one non-serious event at or above the registry's 0% reporting threshold.
| Arm | Participants affected of at risk |
|---|---|
| Controlgroup | 0 of 33 |
| Intervention Group | 0 of 34 |
The registry lists a control-group at-risk count of 33 and an intervention-group at-risk count of 34. For serious adverse events, the corresponding affected counts are 0 in the control group and 0 in the intervention group. For other adverse events, the affected counts are also 0 in each group. These are the recorded counts; they should be read as registry entries, not as proof that no event of any kind occurred.
Deaths are recorded as null for both groups. That means death counts are not reported in the registry record; it should not be interpreted as a reported count of zero. The registry also lists no serious-event terms, but does not give additional detail on event collection, definitions, monitoring period, or completeness of reporting.
Safety counts require context about ascertainment and follow-up. The record does not report whether the at-risk counts apply throughout the study or at a particular period, nor does it describe how adverse events were solicited or verified. Consequently, these figures alone cannot establish the full safety experience or compare risks beyond the recorded counts.
12. What the Result Does, and Does Not, Mean
The registry establishes that this was a completed randomized, parallel-group study of a combined exercise and behavioural approach, with ordinary life as the control-group instruction. It identifies the BBS as the primary endpoint and gives its direction and assessment schedule. These details clarify what the study was designed to examine.
The registry does not report the numerical BBS results or a group comparison. Therefore, the record does not show whether balance scores differed between groups, how large any difference was, or how precisely it was estimated. The absence of a reported estimate is not evidence of no difference, just as the study’s completion status is not evidence of a particular outcome.
The named measure captures balance on a scale whose higher scores indicate better balance. It does not encompass every aspect of disability, physical activity, psychosocial status, or health. The broader outcomes in the study summary indicate that the project had wider interests, but numerical results for those domains are not reported in the registry record.
In general, a randomized design can support a comparison between assigned groups when its conduct and analysis are adequately described. Here, information on allocation implementation, masking details, adherence, missing assessments, analysis populations, and statistical methods is not reported. Those gaps limit assessment of how the planned comparison was carried out and how much confidence to place in any estimate.
The registry’s safety entries record zero serious and zero other adverse events in each group, with deaths not reported. These entries should be interpreted narrowly and do not replace detailed safety reporting. Taken together, the record supports a description of the study question and design, but not a conclusion about the size, direction, or clinical meaning of the primary outcome result.
13. Why This Trial Matters Statistically
This trial is statistically notable for pairing a randomized group comparison with repeated measurement of a functional scale. The BBS is recorded at baseline and at several follow-up times, allowing the study to pose questions about balance both at particular assessments and across follow-up. Those questions require a clearly defined contrast and an analysis that accounts for the structure of the measurements. The registry does not report those analysis details.
The endpoint also illustrates why naming a primary measure matters. The study summary emphasizes disability and a broad set of physical and psychosocial aims, while the primary measure recorded in the registry is balance. A specific scale can make an outcome more operational, but the scope of its interpretation should remain aligned with what it measures. Balance scores should not be treated as a complete account of disability or of every intended outcome domain.
Planning assumptions and observed results answer different questions. The registry describes a sample-size planning illustration based on the observed effect and a stated set of assumptions. Such a calculation is hypothetical and does not reveal the precision of the results actually observed. Because numerical endpoint estimates and uncertainty are not reported in the registry record, the trial’s achieved precision cannot be assessed from the information recorded.
Finally, the outcome and analysis details are important for interpreting a completed trial. Without numerical results, missing-data information, and a stated analysis approach, the randomized design alone is not enough to quantify the evidence. The record is useful for identifying the intended comparison, but it leaves the central statistical result unresolved.
14. Limitations
- The posted summary statistics are the only data these results rest on; patient-level data, full protocols and statistical analysis plans are not available.
- Recalculated results are simple, unadjusted calculations from posted summaries. They do not replace the sponsor's prespecified analysis.
The most direct limitation for interpretation is that the registry record does not report numerical primary-outcome results. Group means, standard deviations, changes, and a between-group estimate are not reported. No confidence interval or p-value is reported for the BBS comparison, so neither the magnitude nor precision of the result can be assessed.
The registry describes the scale and its timing but does not report the statistical model or the contrast chosen for the primary analysis. It is therefore unclear whether the intended inference concerned a follow-up score, change from baseline, or a pattern across assessments. The statistical analysis plan is not reported in the registry record.
Participant flow and data availability are also not reported. The enrollment figure does not indicate how many participants were assessed at each follow-up or included in each analysis. Reasons for missing data, adherence to the exercise program, and deviations from the intervention are not reported. These omissions limit evaluation of how closely the analyzed data represent the planned randomized comparison.
The record identifies the trial as single-masked but does not state who was masked or how masking was implemented. It also does not provide eligibility criteria or baseline characteristics, limiting assessment of the population to which the findings might apply. The study summary lists broad intended outcomes, but their full definitions, results, and multiplicity handling are not reported. Finally, the safety entries do not describe the ascertainment process, and deaths are not reported. These are limitations of the information in the registry record, not conclusions about what the investigators may have collected or analyzed.
15. Related Tutorials
16. Related Statistical Calculators
17. Sources
- ClinicalTrials.gov: Effect of Intensified Physical Activity for Patients With Stroke - a Combined Physical and Behavioural Approach — NCT01161329.
- Registry record last updated 2016-07-11; status last verified 2016-05.
- Results first posted 2016-07-11.
- Data retrieved from ClinicalTrials.gov on 2026-11-09.
- Group sizes, means, event counts and sponsor-reported p-values are reproduced as posted. Effect estimates, confidence intervals and p-values not attributed to the sponsor are independently calculated from the posted summary statistics.
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18. Record Summary
The registry record describes a completed Phase 1 randomized, single-masked, parallel-group study sponsored by Uppsala University. It reports enrollment of 67, a start date of 2009-09, and primary completion in 2012-07. The intervention was the High-Intensity Functional Exercise Program, with group exercise two times/week and motivational discussions; the control group was instructed to live ordinary life.
The primary endpoint is the Berg Balance Scale, summarized as a mean and standard deviation, with higher scores indicating better balance on a 0-56 Points scale. Assessments were scheduled at baseline, after 3, 6 months and after 1 year. Numerical endpoint results and the statistical analysis details are not reported in the registry record.
Serious and other adverse-event counts are recorded as zero in both groups. Death counts are not reported. The record therefore establishes the study’s design and intended endpoint but does not allow a quantitative interpretation of its primary outcome.